A Phase 1 interventional study of CKD-512 and Pembrolizumab in Advanced Solid Tumors and Metastatic Solid Tumors, sponsored by Chong Kun Dang Pharmaceutical. Recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment
The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.
Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose Level(DL) 1 to DL 6
Drug: CKD-512
DL N to DL N+2, combination with Pembrolizumab
Drug: CKD-512 · Combination Product: Pembrolizumab
Orally administered BID
Intravenous (IV) Infusion
Part A: Maximum tolerated dose (MTD) or Optimal biologically effective dose (OBED)
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
Time frame: Up to 2 years
Part B: Recommended dose for expansion (RDE)
Number and proportion of subjects who experience at least 1 DLT based on incidence, nature, and severity of TEAEs and SAEs graded according to NCI-CTCAE version 5.0 as well as on changes from baseline assessments.
Time frame: Up to 2 years
Safety and tolerability
Incidence and severity of TEAEs, incidence of SAEs and TRAEs etc. according to the NCI-CTCAE version 5.0
Time frame: Up to 2 years
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration of CKD-512
Time frame: Up to 2 years
Cmax at steady state (Cmax_ss)
Cmax\_ss is defined as the maximum observed plasma concentration of CKD-512 at steady state
Time frame: Up to 2 years
Area Under the Curve to the last measurable concentration (AUClast)
AUClast is defined as the area under the plasma concentration-time curve of CKD-512 from the time of dosing to the time of the last measurable concentration.
Time frame: Up to 2 years
Area Under the Curve over the dosing interval tau (AUCtau)
AUCtau is defined as the area under the plasma concentration-time curve of CKD-512 over a dosing interval (tau), usually at steady state.
Time frame: Up to 2 years
Overall Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first documented objective tumor response (CR or PR) assessed according to RECIST or iRECIST criteria, until the date of the first documented disease progression or death from any cause, whichever occurs first.
Time frame: Up to 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD), assessed according to RECIST version 1.1 or iRECIST criteria.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of treatment initiation to the date of the first documented disease progression or death from any cause, whichever occurs first, assessed according to RECIST version 1.1 or iRECIST criteria.
Time frame: Up to 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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